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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ABBOTT VASCULAR STEERABLE GUIDE CATHETER 03 VALVE REPAIR

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ABBOTT VASCULAR STEERABLE GUIDE CATHETER 03 VALVE REPAIR Back to Search Results
Model Number SGC0301
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Thrombosis (2100)
Event Date 07/30/2020
Event Type  Injury  
Manufacturer Narrative
The customer reported the device is not returning. Investigation is not yet complete. A follow up report will be submitted with all additional relevant information.
 
Event Description
It was reported that this was a mitraclip procedure to treat grade 4 mixed etiology mitral regurgitation (mr). After the steerable guide catheter (sgc) crossed the inter-atrial septum, a clot was noted on the sgc. Attempt was made to aspirate the clot, but it was not successful. The anticoagulant, angiomax was administered to dissolve the clot, but after ten to 15 minutes, the clot did not dissolve. It was decided to abort the procedure and remove the sgc. After the sgc was removed, no clot was visible on the sgc, but it was seen in the patient's right atrium, near the septum. There were no adverse patient effects and no clinically significant delay in the procedure. There was no additional information provided.
 
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Brand NameSTEERABLE GUIDE CATHETER 03
Type of DeviceVALVE REPAIR
Manufacturer (Section D)
ABBOTT VASCULAR
26531 ynez rd.
temecula CA 92591 4628
Manufacturer (Section G)
ABBOTT VASCULAR, REG # 3005070406
3885 bohannon drive
menlo park CA 94025
Manufacturer Contact
lindsey bell
26531 ynez rd.
temecula, CA 92591-4628
9519143996
MDR Report Key10445576
MDR Text Key204170082
Report Number2024168-2020-07043
Device Sequence Number1
Product Code DRA
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K161985
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation
Type of Report Initial,Followup
Report Date 09/29/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/24/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date05/07/2021
Device Model NumberSGC0301
Device Catalogue NumberSGC0301
Device Lot Number00507U139
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received09/15/2020
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured05/07/2020
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 08/24/2020 Patient Sequence Number: 1
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